Oral & Maxillofacial Surgery

Following the encouraging publications from the last couple of years, we start seeing more and more patients being treated with Aclasta® (zoledronic acid 5 mg) for osteoporosis. Since this yearly infusion increases bone mineral density (BMD) at the lumbar spine significantly ( better than oral risedronate 5mg taken daily ) and has the advantage of improved compliance, it is used as a replacement therapy for the “per os bisphosphonates”.Recently I started having patients taking this yearly infusion and needing periodontal surgery, implants or extractions. Since there is no reports regarding complications or treating adjustments for these kind of patients- I was wondering whether any one of you can share his thoughts and/or experience ??Zoledronic acid, the active ingredient of Aclasta, is also available under the trade-name Zometa® (zoledronic acid 4mg) for use in oncology indications, and we all know the complications related to this IV intake, especially regarding osteonecrosis of the jaws.

Replies

Hi Carry,
Many thanks to you and to Larry for the comprehensive reply.
I understand the message ...and i appreciate much Larry's attitude although i am not exactly the professional to judge...
But certainly i will keep my eyes open!!
However, it is still not clear to me what would be the suggested "protocol" regarding a "real" patient that had already been administered Reclast a half a year ago, and i have to extract her two upper molars?? should i wait another 3-4-5-6 months considering those teeth are advancely involved with periodontitis...???

Cary Feuerman, DMD said:

OK Cobi. Here is his response:

"Hello Cary; see my inserts below. In the USA, it is called "Reclast" and isgiven IV --- once a year (every other year if renal insufficiency is present).It is over-marketed and very expensive. Giving a bisphosphonate this way solelyfor "compliance" reasons doesn't justify the cost. We can track compliance bypharmacy tracking of refills.

First, nobody here gives daily oral bisphosphonate Rx --- as mentioned by yourIsraeli colleague. Fosamax (once/week) is now generic and very inexpensive.Even a branded once/month pill would be lots cheaper than IV. We should use IVbisphosphonates for osteoporosis Rx only if it is essential that the patientgets bisphosphonate Rx and the pt. has an esophageal issue (like achalasia) orhas gastric intolerability.

Unfortunately, both pts. and docs are being seduced by marketing and the docscan make $$$ by charging for an in-office IV infusion. Hence, we are seeing moreand more inappropriate use.

RE: ONJ of the jaw, I heard a presentation (at the Atlanta meetings last month)by a great speaker from Houston (an endocrinologist and a lawyer) who associatesw/ MD Anderson cancer hosp. and who has a huge data bank. The occurance w/ oralagents continues to be very small --- < 0.001% in pts. who don't already have a"rotten mouth". High dose IV Rx for metastatic cancer runs a higher risk ---as per data given to you before.

What about lower dose IV Rx --- such as Reclast?His impression is that it really isn't sig. higher than w/ the oral Rx. Thus,same care and concerns, but not to the magnitude we see w/ metastatic cancer IVuse. In short, no new changes in basic oral protocol needed.

"Hello Cary; see my inserts below. In the USA, it is called "Reclast" and is
given IV --- once a year (every other year if renal insufficiency is present).
It is over-marketed and very expensive. Giving a bisphosphonate this way solely
for "compliance" reasons doesn't justify the cost. We can track compliance by
pharmacy tracking of refills.

First, nobody here gives daily oral bisphosphonate Rx --- as mentioned by your
Israeli colleague. Fosamax (once/week) is now generic and very inexpensive.
Even a branded once/month pill would be lots cheaper than IV. We should use IV
bisphosphonates for osteoporosis Rx only if it is essential that the patient
gets bisphosphonate Rx and the pt. has an esophageal issue (like achalasia) or
has gastric intolerability.

Unfortunately, both pts. and docs are being seduced by marketing and the docs
can make $$$ by charging for an in-office IV infusion. Hence, we are seeing more
and more inappropriate use.

RE: ONJ of the jaw, I heard a presentation (at the Atlanta meetings last month)
by a great speaker from Houston (an endocrinologist and a lawyer) who associates
w/ MD Anderson cancer hosp. and who has a huge data bank. The occurance w/ oral
agents continues to be very small --- < 0.001% in pts. who don't already have a
"rotten mouth". High dose IV Rx for metastatic cancer runs a higher risk ---
as per data given to you before.

What about lower dose IV Rx --- such as Reclast?
His impression is that it really isn't sig. higher than w/ the oral Rx. Thus,
same care and concerns, but not to the magnitude we see w/ metastatic cancer IV
use. In short, no new changes in basic oral protocol needed.